Lead Medical Director



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Directs staff physicians in the PVG department and identifies PVG medical monitor training needs and implementation of appropriate training. Also provides medical management of SAEs and medical oversight of clinical trials to ensure company SOPs, sponsor directives, and regulatory requirements are followed. Other responsibilities include medical review of clinical study reports, attending and presenting at investigator and sponsor meetings, providing medical consultation to sponsors and project team members for clinical trial activities including timeframe business development through marketing application.

Education and Experience:
  • MD (active US license required)--Therapeutic expertise is flexible
  • 3-5 years of pharmaceutical industry experience including direct line management & leadership experience
  • 2 years medical affairs/pharmacovigilance/ SAE review experience
  • Or equivalent combination of knowledge, skills and abilities to perform the essential job functions
Knowledge, Skills and Abilities:
  • Mastery of basic medical management tasks such as SAE review, lab review, protocol inquiries and listing review
  • Ability to effectively mentor others
  • Ability to effectively teach topics such as process procedures, medical concepts and business direction
  • Leadership skills
  • Strong medical knowledge
  • Strong analytical skills
  • Excellent oral and written communication skills
  • Ability to communicate with individuals at all levels (administrative to key thought leaders)
  • Excellent interpersonal and team building skills
  • Excellent negotiating skills
  • Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information, and problem solve
  • Ability to exercise creativity and judgment
  • Expert knowledge of regulatory guidelines for adverse event reporting for serious/unexpected events
  • Expert knowledge of Federal Guidelines and GCPs, including ICH/regional regulatory safety reporting requirements
  • Familiar with guidelines for IND and NDA submissions and international guidelines for conduct of clinical studies
  • Working knowledge of biostatistics, data management, and clinical operations' procedures
  • Expert knowledge of the drug development process
  • Ability to effectively and efficiently manage resources and budgets
PPD is an Equal Opportunity Employer
Additional Information
Location | North Carolina | | Morrisville Start Date 2013-07-09
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 09-Jul-2013

Contact Information
Company Name Pharmaceutical Product Development Telephone No Not Provided
Contact Name Site Link Not Provided


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